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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01207960
Other study ID # 2007-137-f-S
Secondary ID
Status Completed
Phase N/A
First received June 29, 2010
Last updated May 3, 2012
Start date January 2010
Est. completion date September 2011

Study information

Verified date May 2012
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find out whether Eye Movement Desensitization and Reprocessing (EMDR) is effective in the treatment of patients with dental phobia.


Description:

Dental phobia represents a clinical condition that affects 5-15% of the community and is characterized by severe anxiety of dental treatment which leads to avoidance of treatment and, as a consequence, severe dental as well as psychosocial problems.

Eye Movement Desensitization and Reprocessing (EMDR) has been developed for the treatment of patients with post traumatic stress disorder (PTSD). Its efficacy in PTSD patients has often been demonstrated in randomized controlled trials.

Recently it has been demonstrated that dental phobia is often induced by traumatic events during dental treatment and goes along with symptoms of PTSD in numerous patients.

A pilot study (de Jongh et al. 2002) gave hints on the efficacy of EMDR in four dental phobia patients with a history of traumatization during dental treatment.

This randomized wait-list control study aims to evaluate the efficacy of EMDR in a larger sample of dental phobia patients.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- dental phobia according to the World Health Organization´s International Classification of Diseases, ICD-10 (F40.2)

Exclusion Criteria:

- schizophrenic disorder

- severe depression

- severe dissociative disorder

- organic brain disease

- anorexia nervosa (body mass index, BMI < 17)

- suicidality

- severe cardio-vascular disease

- ophthalmic disease

- pregnancy and lactation

- psychopharmacological treatment

- substance abuse

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Eye Movement Desensitization and Reprocessing (EMDR)
The intervention consists of three 90-minute sessions of individual psychotherapy. Sessions take place weekly according to a treatment manual.

Locations

Country Name City State
Germany Psychosomatics in Dentistry, Dept. of Prosthodontics & Material Science, University Hospital Muenster Muenster

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (2)

de Jongh A, Fransen J, Oosterink-Wubbe F, Aartman I. Psychological trauma exposure and trauma symptoms among individuals with high and low levels of dental anxiety. Eur J Oral Sci. 2006 Aug;114(4):286-92. — View Citation

De Jongh A, van den Oord HJ, ten Broeke E. Efficacy of eye movement desensitization and reprocessing in the treatment of specific phobias: Four single-case studies on dental phobia. J Clin Psychol. 2002 Dec;58(12):1489-503. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Dental anxiety Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS). 4 weeks No
Primary Dental anxiety Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS). 3 months No
Primary Dental anxiety Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS). 12 months No
Secondary General psychopathology General psychopathology is assessed by the Brief Symptom Scale (BSI). 4 weeks, 3 months, 12 months No
Secondary Anxiety and depression Anxiety and depression are assessed by the Hospital Anxiety and Depression Scale (HADS). 4 weeks, 3 months, 12 months No
Secondary Behavioral test Dentral anxiety is assessed during a dental visit before and after treatment/wait-list control condition by means of a standardized behavior obeservation and interview. 4 weeks No
Secondary Dental treatment Does the patient tolerate dental treatment within 3 and 12 months after Eye Movement Desensitization and Reprocessing (EMDR)? 3 months, 12 months No
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